FDA Moves to Reduce Unnecessary Radiation Exposure

The U.S. Food and Drug Administration (FDA) has unveiled an initiative to reduce unnecessary radiation exposure from <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">medical imaging. The initiative focuses on three procedures with high radiation doses: Computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to total radiation exposure within the U.S. population, using much higher radiation doses than other radiographic procedures, such as standard and dental X-rays and mammography.

Although all medical procedures pose risks, these procedures expose patients to ionizing radiation, a type of radiation that can increase a person’s lifetime cancer risk. Accidental exposure to very high amounts of radiation can cause injuries, such as skin burns, hair loss, and cataracts.

“The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The goal of FDA’s initiative is to support the benefits associated with medical imaging while minimizing the risks.”

While there is some disagreement over the extent of the cancer risk associated with exposure to radiation from medical imaging, there is broad agreement that steps can and should be taken to reduce unnecessary radiation exposure. For example, the radiation dose associated with a CT abdomen scan is the same as from about 400 chest X-rays, whereas a dental X-ray uses about one-half the dose of a chest X-ray.

Through the FDA’s regulatory oversight of medical imaging devices and through collaboration with other federal agencies and health care professional groups, the FDA is advocating adoption of two principles of radiation protection: Appropriate justification of the radiation procedure and optimization of the radiation dose used during each procedure. “Working together,” said Shuren, “the FDA and other organizations hope to help patients get the right imaging exam, at the right time, with the right radiation dose.”

The FDA intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices to incorporate important safeguards into the design of machines to develop safer technologies and provide appropriate training to support safe practitioner use. The agency will hold a public meeting on March 30-31, 2010, to solicit input on what requirements to establish; for instance, a requirement that devices display, record, and report equipment settings and radiation dose; an alert for users when the dose exceeds a diagnostic reference level (the optimal dose for most patients); training for users; and a requirement that devices capture and transmit radiation dose information to a patient’s electronic medical record and national dose registries.

The FDA and the Centers for Medicare and Medicaid Services are collaborating to incorporate key quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals. The FDA recommends health care professional organizations continue to develop, in collaboration with the agency, diagnostic radiation reference levels for medical imaging procedures, and increase efforts to develop one or more national registries for radiation doses to pool data from many imaging facilities nationwide and capture dose information from a variety of imaging studies to help define nonexistent diagnostic reference levels, validate existing levels, and provide benchmarks for health care facilities to use in individual imaging studies.

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